Herbal composition for treatment of neurodegeneration and neuronal dysfunction

ABSTRACT

This invention provides methods of using various herbal compositions to treat neurodegenerative diseases and neuronal dysfunctions, said compositions comprise a combination of  Radix angelica sinensis  (DangGui),  Ligusticum chuanxiong  (ChuanXiong),  Hirudo  (ShuiZhi),  Polygonatum sibiricum  (HuangJing),  Carthamus tinctorius  (Hong Hua),  Astragalus membranaceus  (HuangQi), and  Glycyrrhiza uralensis  (Gancao).

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation-in-part application of U.S. Ser. No. 10/442,865,filed May 22, 2003, now U.S. Pat. No. 7,205,004 which is a continuationapplication of International Application PCT/IB01/02859, filed Nov. 21,2001, which claims priority of U.S. Ser. No. 60/253,013, filed Nov. 22,2000. The entire contents and disclosures of the preceding applicationsare incorporated by reference into this application.

Throughout this application, various references or publications arecited. Disclosures of these references or publications in theirentireties are hereby incorporated by reference into this application inorder to more fully describe the state of the art to which thisinvention pertains.

FIELD OF THE INVENTION

This invention relates to methods of using herbal compositions to treatneuronal injuries, neuronal dysfunction and neurodegeneration.

BACKGROUND OF THE INVENTION

BuNaoGao (BNG) is a cocktail of Chinese medicine. This formulationconsists of 14 ingredients and was invented by Dr. YongChao Xia(Provincial Hospital of Chinese medicine. LanZhou, P.R. China). BuNaoGaowas designed to treat various forms of neuronal injuries and neuronaldysfunctions and neurodegeneration, i.e. head, and spinal cord injury,cerebral palsy, motor neuron diseases (1-5). The early explorativeclinical work was carried out in Chinese patient population in the late70's and early 80's. BuNaoGao clinical trials for the treatment of headspinal cord injury, motor neuron diseases and other forms ofdegenerative diseases were carried out in China during the period of1989-1994 (5). Results of the BuNaoGao clinical trial had gone throughpeer reviewed process in 1994 and had since acquired the regulatoryapproval from the Chinese government for human use under supervision.

The present invention report results of using BuNaoGao in treatingvarious forms of neuronal injuries, neuronal dysfunction andneurodegeneration.

SUMMARY OF THE INVENTION

In one embodiment, the present invention provides a method of treatingneuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Ligusticumchuanxiong (ChuanXiong), Hirudo (Shuizhi), and Polygonatum sibiricum(Huangjing), wherein the g/kg body weight dosages can be increased up to2.5 times if the body weight of the patient is less than 40 kg.

In another embodiment, the present invention provides a method oftreating neuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Carthamustinctorius (Hong Hua), Hirudo (Shuizhi), and Polygonatum sibiricum(HuangiJing), wherein the g/kg body weight dosages can be increased upto 2.5 times if the body weight of the patient is less than 40 kg.

In another embodiment, the present invention provides a method oftreating neuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Ligusticumchuanxiong (ChuanXiong), Hirudo (ShuiZhi), Polygonatum sibiricum(HuangJing), and Astragalus membranaceus (HuangQi), wherein the g/kgbody weight dosages can be increased up to 2.5 times if the body weightof the patient is less than 40 kg.

In another embodiment, the present invention provides a method oftreating neuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Carthamustinctorius (Hong Hua), Hirudo (ShuiZhi), Polygonatum sibiricum(HuangJing), and Astragalus membranaceus (HuangQi), wherein the g/kgbody weight dosages can be increased up to 2.5 times if the body weightof the patient is less than 40 kg.

In another embodiment, the present invention provides a method oftreating neuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Ligusticumchuanxiong (ChuanXiong), Hirudo (Shuizhi), Polygonatum sibiricum(Huangjing), and Glycyrrhiza uralensis (Gancao), wherein the g/kg bodyweight dosages can be increased up to 2.5 times if the body weight ofthe patient is less than 40 kg.

In another embodiment, the present invention provides a method oftreating neuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Carthamustinctorius (Hong Hua), Hirudo (Shuizhi), Polygonatum sibiricum(Huangjing), and Glycyrrhiza uralensis (Gancao), wherein the g/kg bodyweight dosages can be increased up to 2.5 times if the body weight ofthe patient is less than 40 kg.

In one embodiment, the present invention provides a method of treatingneuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Ligusticumchuanxiong (ChuanXiong), Hirudo (ShuiZhi), Polygonatum sibiricum(HuangJing) Glycyrrhiza uralensis (Gancao) and Astragalus membranaceus(HuangQi), wherein the g/kg body weight dosages can be increased up to2.5 times if the body weight of the patient is less than 40 kg.

In another embodiment, the present invention provides a method oftreating neuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Ligusticumchuanxiong (ChuanXiong), Hirudo (ShuiZhi), Polygonatum sibiricum(HuangJing), and one or more of the following: Astragalus membranaceus(HuangQi), Lycium chinense mill (GouQiZi), Curculigo orchioides(XianMao), epimedium grandiflorum (YinYangHuo), plastrum testudinis(ShengGuiBan), Cornus officinalis (ShanZhuYu), Psoralea corylifolia(BuGuZhi), Leonurus heterophyllus (YiMuCao), Paeonia rubrae (ChiShao),and Glycyrrhiza uralensis (Gancao).

In another embodiment, the present invention provides a method oftreating neuronal injuries, neuronal dysfunction and neurodegeneration,comprising the step of administering to a patient in need thereof acompositing comprising Radix angelica sinensis (DangGui), Carthamustinctorius (Hong Hua), Hirudo (ShuiZhi), Polygonatum sibiricum(HuangJing), and one or more of the following: Astragalus membranaceus(HuangQi), Lycium chinense mill (GouQiZi), Curculigo orchioides(XianMao), epimedium grandiflorum (YinYangHuo), plastrum testudinis(ShengGuiBan), Cornus officinalis (ShanZhuYu), Psoralea corylifolia(BuGuzhi), Leonurus heterophyllus (YiMuCao), Paeonia rubrae (ChiShao),and Glycyrrhiza uralensis (Gancao).

DETAILED DESCRIPTION OF THE INVENTION

According to the theory of Chinese medicine, neurodegenerative diseasesbelong to the category of Qi deficiency, “liver” and “kidney” weakness(Wei Zheng or Wei Syndrome). The terms “liver” and “kidney” in Chinesemedicine do not merely include the liver and kidney in modern anatomicaldefinition. The definition of “liver” includes liver, part of the CNS,autonomic nervous system, blood and visual systems; whereas thedefinition of “kidney” includes urinary system, reproductive system,part of the endocrine system and nervous system. BuNaoGao was designedto achieve its neuronal supporting effect through the nourishment of“liver” and “kidney”, and the nourishment and mobilization andharmonization of “Qi” and “blood”. Experimental studies in animal modelshad revealed its effect in improving blood circulation, reduction ofblood viscosity and effect in immune regulation (5, 29). The approach ofBNG to tackle neurodegenerative disease and neurodegeneration wasthrough a mechanism of systemic nourishment and regulation.

Mental retardation and cerebral palsy: Our diagnosis of mentalretardation also includes cerebral Palsy. According to the statisticaldata reported in America in 1973, the worldwide prevalence of mentalretardation is 3% (mild type: 2.5%, moderate type. 0.5%); its prevalencein China is 0.5-2.7% (mild type) and 0.3-1% (severe type); theprevalence of cerebral palsy is 0.1-0.2% worldwide, and 0.1-0.4%(approximately 2 million in China). According the information releasedby American National Health Institute: more than 500,000 Americans havecerebral palsy (this information may also be considered as a referencefor its global trend). The number of children and adults it affects hasremained essentially unchanged or perhaps risen slightly over the past30 years.

For paralysis or other disability caused by brain/spinal cord injury:There are currently 5.3 million Americans living with disability causedby head and spinal cord injury. Each year, at least 1.5 million peoplesustain brain injury (at a speed on every 21 seconds). This publichealth concern ranks as the leading cause of death and disability inchildren and young adults. Currently, prevention is the only known curefor brain injury. This statistics came from the information released bythe Brain Injury Association, Inc. (Alexandria, Va., USA). Thisinformation may also be used as a reference for the worldwide trend ofbrain injury.

Dementia of all types: e.g. Alzheimer's disease (AD), the most commoncause of dementia among people age 65 and older. It was estimated thatup to 4 million people in America currently suffer with the disease, andthe prevalence (the number of people with the disease at any one time)doubles every 5 years beyond age 65. Approximately 360,000 new cases areestimated to emerge each year and to increase as the population ages(According to the 2000 progress report on Alzheimer's disease fromNational Institute of Health of America). In China, over 5 millionspeople above the age 65 suffer from senile dementia (according to theinformation of a large-scale study by the Beijing Center of Gerontology,P.R. China, September 2002).

Motor neuron disease: Amyotrophic lateral sclerosis (ALS), oftenreferred to as “Lou Gehrig's disease,” is a fatal neurodegenerativedisease and is the most common and the most severe form of motor neurondiseases. The vast majory of ALS patients dies within 2-5 years afterdiagnosis. Major clinical trials of the last 10 years has repeatedlyrevealed approximately 50% fatality or tracheotomy-free survival by theend of 15-18 months follow up (6-8). RILOZOLE is currently the only FDAapproved drug for ALS and has proven in clinical trials to prolong ALSsurvival by approximately 3 months during the first 15 months of its use(6-9).

Treatment of all above conditions has been one of the biggest challengesto our biomedical field. Treatment regimes worldwide involveneuroprotectants and physical therapies, and these regimes have beenexpensive with only limited clinical benefits. No generally-acceptedeffective treatment is so far available. In recent years, there has beensome progress in using Chinese Medicine for the treatment of the abovediseases; however, their effectiveness has been limited due to bigcase-to-case variations and low reproducibility.

This invention was developed based on the inventor's over 30 years ofclinical practice and academic exploration. The therapeutic scope ofthis invention touches the most sensitive and challenging areas ofmodern biomedical fields. Its efficacy in treating such a wide range ofcomplicated diseases, its reproducibility, low toxicity and high socialbenefit will establish its position in the future biomedical field.

In one embodiment, 2 lozenges is a standard daily dose. For a personwith body weight of 50-60 kg, the dosage range and the dosage present in2 lozenges are listed below for the herbal ingredients: Radix angelicasinensis (DangGui) 0.82 g-3.3 g/Kg body weight, if 80 g/daily, 1.3-1.6g/Kg; Ligusticum chuanxiong (ChuanXiong) 0.1-1.2 g/Kg body weight, if 20g/daily, 0.33-0.4 g/Kg; Hirudo (ShuiZhi) 0.1-0.4 g/Kg body weight, if 10g/daily, 0.16-0.2 g/Kg; Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg,if 20 g/daily, 0.33-0.4 g/Kg; Astragalus membranaceus (HuangQi) 0.315g-1.2 g/Kg body weight, if 30 g/daily, 0.48-0.6 g/Kg; Lycium chinensemill (GouQizi) 0.1-1 g/Kg, if 12 g/daily, 0.24-0.24 g/Kg; Curculigoorchioides (XianMao) 0.1-1 g/Kg, if 9 g/daily, 0.15-0.18 g/Kg; epimediumgrandiflorum (YinYangHuo) 0.1-1 g/Kg, if 9 g/daily, 0.15-0.18 g/Kg;plastrum testudinis (ShengGuiBan) 0.1-1 g/Kg, if 15 g/daily, 0.25-0.3g/Kg; Cornus officinalis (ShanzhuYu) 0.1-1 g/Kg, if 10 g/daily, 0.16-0.2g/Kg; Psoralea corylifolia (BuGuZhi) 0.1-1 g/Kg, if 12 g/daily,0.24-0.24 g/Kg; Leonurus heterophyllus (YiMucao) 0.1-1 g/Kg, if 20g/daily, 0.33-0.4 g/Kg; Paeonia rubrae (ChiShao) 0.1-1 g/Kg, if 20g/daily, 0.33-0.4 g/Kg; Glycyrrhiza uralensis (Gancao) 0.06-0.21 g/Kg,if 6 g/daily, 0.1-0.12 g/Kg.

The present invention provides methods of treating neurodegenerativediseases or degenerative conditions. As an example, the followingexamples present data relating to treating patients with cerebral palsy,motor neuron disease/amyotrophic lateral sclerosis, spinal cerebellaataxia etc. Taking the present and prior disclosures as a whole, one ofordinary skill in the art would recognize that the present invention isnot limited to treating only cerebral palsy, spinal cerebella ataxia(SCA), amyotrophic lateral sclerosis. The methods of treatment disclosedherein would be applicable to other neurodegenerative diseases. As usedherein, “neurodegenerative diseases” include, but are not limited to,amyotrophic lateral sclerosis, Alzheimer disease, Olivopontocerebellaratrophy, and CNS inflammatory diseases such as myelitis, multiplesclerosis.

In one embodiment of the present invention, there is provided a methodof treating neuronal injuries or neurodegenerative diseases, comprisingthe step of administering to a patient in need thereof a compositingcomprising Radix angelica sinensis (DangGui) 0.82-3.3 g/kg body weight,Ligusticum chuanxiong (ChuanXiong) 0.1-1.2 g/kg body weight, Hirudo(Shuizhi) 0.1-0.4 g/kg body weight, and Polygonatum sibiricum(HuangJing) 0.2-0.8 g/kg body weight, wherein the g/kg body weightdosages can be increased up to 2.5 times if the body weight of thepatient is less than 40 kg. In one embodiment, the composition isadministered daily.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Carthamus tinctorius (Hong Hua)0.1-1.2 g/kg body weight, Hirudo (Shuizhi) 0.1-0.4 g/kg body weight, andPolygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Ligusticum chuanxiong (ChuanXiong)0.1-1.2 g/kg body weight, Hirudo (ShuiZhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, andAstragalus membranaceus (HuangQi) 0.315-1.2 g/kg body weight.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Carthamus tinctorius (Hong Hua)0.1-1.2 g/kg body weight, Hirudo (ShuiZhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, andAstragalus membranaceus (HuangQi) 0.315-1.2 g/kg body weight.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Ligusticum chuanxiong (ChuanXiong)0.1-1.2 g/kg body weight, Hirudo (ShuiZhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, andGlycyrrhiza uralensis (Gancao) 0.06-0.21 g/kg body weight.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Carthamus tinctorius (Hong Hua)0.1-1.2 g/kg body weight, Hirudo (ShuiZhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, andGlycyrrhiza uralensis (Gancao) 0.06-0.21 g/kg body weight.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Ligusticum chuanxiong (ChuanXiong)0.1-1.2 g/kg body weight, Hirudo (ShuiZhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, Astragalusmembranaceus (HuangQi) 0.315-1.2 g/kg body weight, and Glycyrrhizauralensis (Gancao) 0.06-0.21 g/kg body weight. In one embodiment, thecomposition is administered daily. In another embodiment, the g/kg bodyweight dosages can be increased up to 2.5 times if the body weight ofthe patient is less than 40 kg.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Ligusticum chuanxiong (Chuanxiong)0.1-1.2 g/kg body weight, Hirudo (Shuizhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, and one ormore of the following: Astragalus membranaceus (HuangQi) 0.315 g-1.2g/Kg body weight, Lycium chinense mill (GouQiZi) 0.1-1 g/Kg, Curculigoorchioides (XianMao) 0.1-1 g/Kg, epimedium grandiflorum (YinYangHuo)0.1-1 g/Kg, plastrum testudinis (ShengGuiBan) 0.1-1 g/Kg, Cornusofficinalis (ShanZhuYu) 0.1-1 g/Kg, Psoralea corylifolia (BuGuZhi) 0.1-1g/Kg, Leonurus heterophyllus (YiMuCao) 0.1-1 g/Kg, Paeonia rubrae(ChiShao) 0.1-1 g/Kg, Glycyrrhiza uralensis (Gancao) 0.06-0.21 g/Kg.

In another embodiment, the composition comprises Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Carthamus tinctorius (Hong Hua)0.1-1.2 g/kg body weight, Hirudo (Shuizhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, and one ormore of the following: Astragalus membranaceus (HuangQi) 0.315 g-1.2g/Kg body weight, Lycium chinense mill (GouQiZi) 0.1-1 g/Kg, Curculigoorchioides (XianMao) 0.1-1 g/Kg, epimedium grandiflorum (YinYangHuo)0.1-1 g/Kg, plastrum testudinis (ShengGuiBan) 0.1-1 g/Kg, Cornusofficinalis (ShanzhuYu) 0.1-1 g/Kg, Psoralea corylifolia (BuGuZhi) 0.1-1g/Kg, Leonurus heterophyllus (YiMuCao) 0.1-1 g/Kg, Paeonia rubrae(ChiShao) 0.1-1 g/Kg, Glycyrrhiza uralensis (Gancao) 0.06-0.21 g/Kg.

The invention being generally described, will be more readily understoodby reference to the following examples which are included merely forpurposes of illustration of certain aspects and embodiments of thepresent invention, and are not intended to limit the invention.

Content of Examples:

EXAMPLE 1 BuNaoGao in the treatment of children with mental retardation(a trial of 133 cases)

EXAMPLE 2 BuNaoGao in the treatment of children with cerebral palsy (atrial of 102 cases)

EXAMPLE 3 BuNaoGao in the treatment of paralysis as a result ofhead/spinal cord trauma (a trial of 66 cases)

EXAMPLE 4 BuNaoGao in the treatment of 23 patients of motor neurondisease

EXAMPLE 5 Treatment of patients in vegetative state (total four cases)

EXAMPLE 6 Treatment of Oliverpontocerebellar atrophy (Dejerine-Thomastype, 3 cases)

EXAMPLE 7 Treatment of hereditary cerebellar ataxia (3 cases)

EXAMPLE 8 Treatment of dementia

EXAMPLE 9 Treatment of 52 patients with sequel of apoplexy withFe-Shou-Yi-Qi-Ho-Xieff” concoction

EXAMPLE 10 Treatment of 50 patients of apoplexy combined withpseudo-bulbar palsy

EXAMPLE 11 Treatment of encephalopathy

EXAMPLE 12 Treatment of multiple sclerosis (MS)

EXAMPLE 13 Treatment of myelitis

EXAMPLE 14 Treatment of polyneuritis (polyneuropathy)

EXAMPLE 1 BuraoGao in the Treatment of Children with Mental Retardation(a Trial of 133 Cases) (10, 34)

1.1 General Information

This clinical trial was carried out between January 1989 and December1992 at the Provincial Hospital of Chinese Medicine, Lanzhou, GanSuProvince, P.R. China. The details are listed in table 1.1

TABLE 1.1 Treatment of children with mental retardation with BuNaoGaoBuNaoGao group Control group Total cases 75 58 Male 45 29 Female 30 29Range in Age 4 months to 14 years 1 year to 14 years (5.8 years inaverage) (5.9 years in average) Age distribution: 0-3 years 28 13 4-6.5years 17 20 6.5 years and above 30 25 IQ (DQ for age < 3 years)Marginal(IQ 70-79) 6 5 Mild(IQ 55-69) 18 8 Moderate(IQ 40-54) 16 11Severe(IQ 25-39) 20 9 Most severe(IQ <24) 15 25 Brain CT scan 26 testedNot tested Cortical atrophy: 12 localized region of reduced densities 5localized region of high density 1 Cerebellum atrophy 1 Arachinoidalcyst 2 Normal 4 Electroencephalography (EEG) 16 tested Not tested Mildlyabnormal 3 Moderately abnormal 7 Highly abnormal 6 Complications andconcomitant diseases Cerebral palsies 69 24 Major epilepsy 17 Minorepilepsy 2 1 Myoclonic epilepsy 6 2 spontaneous movement 6 Congenitalheart disease 1 1 Congenital lip cleft 4 Etiology not availablePremature birth 15 (because all cases were from the Hypoxia duringdelivery 23 city's orphanage hospital) Cesarean section 3 Sequel ofnuclear Jaundice 3 Maternal history of severe infection 3 Sign ofembryonic abortion 1 Unknown 271.2 Treatment Strategy (Table 1.2)

TABLE 1.2 Treatment Strategy of BuNaoGao vs. control groups for mentalretardation BuNao Gao group Control Oral intake of BuNaoGao alone Oralintake of Nao-Fu-Kang* No additional training some also combined withacupuncture, or other medication, massage or planned exercisesHospitalized 23 cases 58 cases (in the orphanage hospital) Out-patients52 cases Dosage <3 yr.: 0.5-1 cube/day <5 yrs: 0.8-1.2 g/day 3-6 yrs: 1cube/day 5-10 yrs: 1.8 g/day >6 yrs: 1-2 cubes/day >10 yrs: 2.4 g/dayDuration of treatment 1 month 24 cases 2 months 25 cases 3 months 14cases 58 cases 4 months  9 cases 6 months  3 cases *Nao-Fu-Kang is acommercially available herbal decoction commonly used for braindysfunctions.1.3 Criteria for Clinical EvaluationDiagnostic Criteria for Mental Retardation

Intelligence obviously below average; IQ lower than average minus 2 SD(IQ <70, SD=15).

Deficits in age-appropriate behaviors.

At developmental stage (less than 18 years of age)

All children who entered the study satisfied the above three criteria.

Measurement of Intelligence

Gesell criteria: children of 4 weeks-3 years of age were evaluated withthis criteria

WPPSI criteria; 4-6.5 years of age

WISC-R criteria: 6.5-16 years of age.

Criteria for Evaluating Therapeutic Effects

(IQ was determined according to international standards)

Notable effect: increase of IQ >15 (including 15)

Improvement: increase of IQ 10-14 (including 10)

Effective: increase of IQ 5-9 (including 5)

No effect: increase of IQ <5

1.4 Results

TABLE 1.3 Therapeutic efficacy of BuNaoGao for children with mentalretardation Effect BuNaoGao (%) Control (%) Total cases 75 58 Notableeffect 27 (36%)  6 (10%) Improvement 17 (23%)  7 (12%) Effective 22(29%) 4 (7%) No effect  9 (12%) 41 (71%) Total effective 66 (88%) 17(29%)

TABLE 1.4 Total effective rate of BuNaoGao and control groups for mentalretardation of different severities Total effective rate SeverityBuNaoGao Control total cases 75 58 Marginal  5/6 (83%) 4/5 (80%) mild 18/18 (100%) 2/8 (25%) moderate  16/16 (100%) 5/11 (45%)  severe 16/20(80%) 5/9 (55%) most severe 11/15 (73%) 1/25 (4%)  total 66/75 (88%)17/58 (29.3%) Total effective rate includes the rates of notable effect, improvementand effective

TABLE 1.5 Analysis of BuNaoGao effect on mental retardation of Differentseverities (75 cases) Notable no total effective Improvement effectiveeffect effective mild (IQ 55-69) 6 7 5 18/18 (100%) moderate(IQ 40-54) 73 6 16/16 (100%) severe(IQ 25-39) 6 4 6 4 16/20 (80%) most severe(IQ<24) 5 2 4 4 11/15 (73%) marginal (IQ 70-79) 3 1 1 1  5/6 (83%) % oftotal 27 17 22 9 66 (36%) (22.7%) (29.3%) (12%) (88%)

TABLE 1.6 Analysis of NaoFuKang (control group) for mental retardationof different severity (58 cases) notable total effective Improvementeffective no effect effective mild (IQ 55-69) 2 6  2/8 (25%) moderate(IQ 40-54) 2 2 1 6 5/11 (45%) severe (IQ 25-39) 1 3 1 4  5/9 (55%) mostsevere (IQ <24) 1 24 1/25 (4%) marginal (IQ 70-79) 1 2 1 1  4/5 (80%) %of Total 6 17 4 41 17 (10.3%) (12.1%) (7%) (70.7%) (29.3%)1.5 Clinical Follow-up

50 out of 75 cases in the BuNaoGao group were followed up for a periodof 3 months to 4 years, the intelligence of all patients were found instable conditions or had continued improvement. No single case ofdeterioration was reported during this period.

1.6 Conclusion and Remarks

For the treatment of children mental retardation using BuNaoGao: Therate for notable effective is significantly higher in BuNaoGao group(36%) than that of the control group (10%). P<0.001. The total effectiverate of the BuNaoGao group (88%) is significantly higher than that ofthe control group (29%). P<0.001. For mild type, the total effectiverate of the BuNaoGao group (100%) is significantly higher than that ofthe control group (25%). P<0.001. For moderate type, the total effectiverate of the BuNaoGao group (100%) is significantly higher than that ofthe control group (45%). P<0.01. For severe and most severe types, thetotal effective rate of the BuNaoGao group (77.1%) is significantlyhigher than that of the control group (18%). P<0.01. Therefore BuNaoGaois found to have significant therapeutic effect on children mentalretardation.

EXAMPLE 2 BuNaoGao in the Treatment of Children with Cerebral Palsy (aTrial of 102 Cases) (11, 33)

2.1 General Information

This clinical trial was carried out between January 1989 and December1992 by the Provincial Hospital of Chinese Medicine, Lanzhou, GanSuProvince. The details are listed in Table 2.1.

TABLE 2.1 BuNaoGao for children with cerebral palsy BuNaoGao groupControl group No. of Cases 78 24 Male 47 14 Female 31 10 Range in Age 4months to 13 years 1 year to 9.5 years (5.9 years in average) (4.1 yearsin average) Age distribution: 0-3 years 34 7 4-6.5 years 21 11 6.5 yearsand above 23 6 Severity by muscle strength Mild(III⁺-V) 9 (11.5%) 11(45.8%) Moderate (II⁺-III) 42 (53.8%) 10 (41.7%) Severe (I⁺-II) 24(30.8%)  3 (12.5%) Most severe (0-I)  3 (3.85%) 0 Type of cerebralpalsies Spastic type 59 11 Athetosis 1 1 Rigidity 1 1 Ataxic type 10Tremor 2 dystonic type 5 11 Severity of paralysis Quadriplegia 64 17Paraplegia 3 3 Hemiplegia 8 3 Monoplegia 1 1 Brain CT scan 29 tested nottested Cortical atrophy: 12 localized region of reduced densities 9localized region of high density 1 Cerebellum atrophy 1 Arachinoidalcyst 2 Normal 3 Electroencephalography (EEG) 21 tested not testedSlightly abnormal 4 Moderately abnormal 11 Highly abnormal 6Complications & concomitant diseases Cerebral feeblemindedness 68 24Major epilepsies 20 pyknolepsy 2 1 Myoclonic epilepsy 4 Spontaneousmovement 3 Congenital heart disease 1 1 Etiology not available*Premature birth 12 (because all cases were from the Hypoxia duringdelivery 23 city's orphanage hospital) Cesarean section 3 Sequel ofnuclear jaundice 3 Maternal history of severe infections 5 Unknown 302.2. Treatment Strategy (Table 2.2)

TABLE 2.2 Treatment Strategy for BuNaoGao vs. control groups forcerebral palsy BuNaoGao group Control Oral intake of BuNaoGao alone Oralintake of Nao-Fu-Kang* No additional training some also combined with orother medications planned exercise, acupuncture, massage Total Cases 7824 Hospitalized 23 24 (in the Orphanage hospital) Out-patients 55 Dosage<3 yrs, 0.5-1 cube/day <5 yrs, 0.8-1.2 g/day 3-6 yrs: 1 cube/day 5-10yrs: 1.8 g/day >6 yrs: 1-2 cubes/day >10 yrs: 2.4 g/day Duration oftreatment 1 month 24 2 months 32 3 months 20 24 4 months  2 *Nao-Fu-Kongis a commercially available herbal decoction commonly used for braindysfunction2.3 Criteria for Clinical Evaluation (the Internationally used Six GradeCriteria)

Cured: movement become normal, muscle strength reach grade V

Notable effect: movement function significantly improved, musclestrength improved over 2 grade.

Effective: movement function improved, muscle strength improved over 1grade.

No effect: no improvement of movement function, muscle strength improvedless than 1 grade.

2.4. Results (Tables 2.3-2.6)

TABLE 2.3 Therapeutic efficacy of BuNaoGao for children with cerebralpalsy BuNaoGao Control Effect (%) (%) total Case 78 24 Cured 7 (9%)   0Notable effect 21 (26.9%) 1 (4.2%)  Effective 46 (59%)   4 (16.7%) Noeffect 4 (5.1%) 19 (79.2%)  Total effective 74 (98.9%) 5 (20.8%)

TABLE 2.4 Total effective rate of BuNaoGao and control for cerebralpalsy of different severities Total effective rate Severity BuNaoGaoControl total cases 78 24 mild  8/9 (88.9%) 4/11 (36.4%) moderate 39/42(92.9%) 1/10 (10%) severe 24/24 (100%)  0/3 (0) most severe  3/3 (100%)  0 (0) total 74/78 (94.9%) 5/24 (20.8%)Total effective rate includes the rate of cured, notable effect andeffective.

TABLE 2.5 Analysis of BuNaoGao effect for cerebral palsy of differentseverities (78 cases) Notable Total Cured effect Effective No effecteffective(%) mild 2 6 1  8/9 (88.9%) moderate 5 9 25 3 39/42 (92.9%)severe 10 14 24/24 (100%) most severe 2 1  3/3 (100%) % of total 7/7821/78 46/78 4/78 74/78 (8.97%) (26.9%) (59%) (5.1%) (94.9%)

TABLE 2.6 Analysis of Nao-Fu-Kang effect (control) for cerebral palsy ofdifferent severities (24 cases) notable no total cured effect effectiveeffect effective(%) Mild 1 3 7 4/11(36.4%) moderate 1 9 1/10(10%) severe3  0/3 (0) most severe 0 (0) % of total 0 1/24 4/24 19/24 5/24 (4.17%)(16.7) (79.2%) (20.8%)2.5 Clinical Follow-Up

60 of 78 cases in the BuNaoGao group were followed up for a period of 3months to 4 years, all patients were found in stable conditions or hadshown continued improvement. No single case of deterioration wasreported.

2.6 Conclusion and Remarks

For the treatment of children cerebral palsy using BuNaoGao: The ratefor notable effective plus cured is significantly higher in BuNaoGaogroup (35.9%) than that of the control group (4.2%), P<0.005. The totaleffective rate of the BuNaoGao group (98.9%) is significantly higherthan that of the control group (20.8%), P<0.005. For mild type ofcerebral palsy, the total effective rate of the BuNaoGao group (88.9%)is significantly higher than that of the control group (36.4%), P<0.01.For moderate type of cerebral palsy, the total effective rate of theBuNaoGao group (92.9%) is significantly higher than that of the controlgroup (10%), P<0.005. For severe type of cerebral palsy, all of the 24cases in BuNaoGao group (100%) showed effective results, and none of the3 cases in the control group showed any effect. For most severe type ofcerebral palsy, all three cases treated by BuNaoGao gained effectiveresults, and no patient of this severity was included in the controlgroup. Therefore BuNaoGao was found to have significant therapeuticeffect on cerebral palsy.

EXAMPLE 3 BuNaoGao in the Treatment of Paralysis as a Result ofHead/Spinal Cord Trauma (a Trial of 66 cases) (1, 30)

3.1 General Information

This clinical trial was carried out between January, 1989 to December,1992 by the Provincial Hospital of Chinese Medicine, Lanzhou, GanSuProvince. The details are listed in Table 3.1.

TABLE 3.1 General information of patients with paralysis resulting fromhead/spinal cord trauma in BuNaoGao group and control group. BuNaoGaogroup Control group Total cases 46 20 Male: 34 15 Female: 12 5In-patients 34 20 Outpatients 12 Range in Age 1.5 to 71 yrs 8 to 50 yrs(average 29 yrs) (average 32 yrs)  0-9 yrs 6 1 10-17 yrs 2 5 18-29 yrs16 0 30-39 yrs 8 6 40-59 yrs 12 8  >60 yrs 2 0 Disease Severity Mild(III⁺-V⁻)* 12 8 Moderate (II⁺-III) 17 4 Severe (I⁺-II) 10 3 Very severe(0-I) 7 5 Duration of illness  <1 month 3 0  1-3 months 8 4  3-6 months5 2 6-12 months 10 3  1-3 years 13 11  3-5 years 5 0 5-10 years 1  15years 1 Cause of injuries Car accident 20 2 Bicycle accident 3Motorcycle accident 1 2 Fall from high places 4 1 Fall from flat ground5 Manslaughter 9 1 Heavy object struck 2 14 surgery 1 ComplicationsHeadache 33 9 Dizziness 31 8 Aphasia 11 2 Dysphasia 15 7 Dysphagia 7 3Sleepiness 5 2 Slow responsiveness 11 3 mentally retarded 12 Decerebralrigidity 4 vegetative states 3 lack of bladder and bowl control 13 5optic nerve atrophy 1 3 blurred vision 3 facial nerve paralysis 3 1epilepsy 7 3 multiple cranial nerve injury 1 1 Brain CT scan 33 tested 7tested normal 7 1 localized region of reduced density 12 4 localizedregion of high density 3 Intracranial hematoma 3 6 Epidural hematoma 4 1Subdural hematoma 1 Subdural fluid 3 Hydrocephalus 2 Brain atrophy 3Brain infarct 2 Skull fracture 14 Electroencephalography (EEG) 40 tested6 tested Normal: 5 Slightly abnormal: 14 1 Moderately abnormal: 16 1Severely abnormal: 5 4 Diagnosis Brain laceration 29 12 Brain lacerationcombined with 1 skull base fracture Intracranial hematoma 8 7 Chronicintracranial hematoma 1 Epidural hematoma 4 Subdural hematoma 1 Brainstem injury (vegetative state) 3 Lingual diagnosis Substance of tonguepinkish (Dan Hong) 8 5 red (Hong) 16 9 dark red (Hong An) 8 3 plain(Dan) 12 2 dark plain (Dan An) 2 1 Tongue coating Thin white coating (BoBai) 8 12 white coating (Bai) 22 2 white glossy coating (Bai Ni) 5 2yellow coating (Huang) 7 3 yellow glossy coating (Huang Ni) 3 3 littlecoating (shao tai) 1 Pulse fine pulse (Xi Mai) 24 stringy pulse (XuanMai) 13 8 stringy large pulse (Xuan Da Mai) 1 stringy fine pulse (XuanXi Mai) 3 rapid pulse (Shu Mai) 1 Slippery pulse (Hua Mai) 5 Deep slowpulse (Chen Huan Mai) 2 Deep stringy pulse 2 (Chen Xuan Mai) Fine rapidpulse (Xi Mai) 1 Deep fine pulse (Chen Xi Mai) 6

TABLE 3.2 Treatment Strategy for BuNaoGao & control groups for paralysisby head/spinal cord trauma BuNaoGao Control Oral intake of Combinedtreatment of BuNaoGao alone Chinese & Western No additional trainingmedicines, acupuncture, or other medications physical therapy Totalcases 46 20 Hospitalized 34 20 Out-patients 12 Dosage 2 cubes/dayDuration of treatment 1 month 10 4 2 months 16 3 3 months 6 2 >3 months14 113.2 Criteria for Clinical Evaluation (The Internationally Used Six-GradeCriteria).

Cured: movement became normal, muscle strength reached to grade V

Notable effect: muscle strength improved over 2 grade.

Effective: muscle strength improved over 1 grade.

No effect: muscle strength improved less than 1 grade.

3.3 Results

TABLE 3.3 Therapeutic efficacy of BuNaoGao for paralysis after headtrauma BuNaoGao Control Effect (%) (%) Total 46 20 Cured  7 (15%) 0Notable 15 (33%) 3 (15%) Effective 21 (46%) 5 (25%) No effect 3 (6%) 12(60%)  Total effective 43 (93%) 8 (40%)

TABLE 3.4 Effective rate of BuNaoGao and control group for paralysis ofdifferent severities Total effective rate Severity BuNaoGao ControlTotal 46 20 Mild(III⁺-V⁻) 10/12 (83%)  3/8 (37.5%) moderate(II⁺-III)16/17 (94.1%)  2/4 (50%) severe(I⁺-II) 10/10 (100%)  3/3 (100%) mostsevere(0-I)  7/7 (100%)  0/5 (0) Total effective 43/46 (93.4%) 8/20(40%)

TABLE 3.5 Analysis of BuNaoGao effect on paralysis of differentseverities (46 cases) Notable No Total Cured effect Effective effecteffective (%) mild (III⁺-V⁻) 6 4 2 10/12 (83.3%) moderate 2 14  1 16/17(94.1%) (II⁺-III) severe (I⁺-II) 7 3 10/10 (100%) most 1 6  7/7 (100%)severe (0-I) % of Total 7 15 21 3 43/46 (93.4%) (15.2%) (32.6%) (45.6%)(6.5%)

TABLE 3.6 Analysis of the control group effect on paralysis of differentseverities (20 cases) Notable No Total Cured effect Effective effecteffective (%) Mild (III⁺-V⁻) 3 5  3/8 (37.5%) Moderate (II⁺-III) 2 2 2/4 (50%) severe (I⁺-II) 3  3/3 (100%) most severe (0-I) 5  0/5 (0) %of Total 0 3 5 12  8/20 (40%) (15%) (25%) (60%)3. 4. Conclusion and Remarks

For the treatment of paralysis after head/spinal cord trauma usingBuNaoGao: The total effective rate of the BuNaoGao group (93%) issignificantly higher than that of the control group (40%). P<0.005. Therate for notable effective plus cured is significantly higher inBuNaoGao group (47.8%) than that of the control group (15%). P<0.025.Therapeutic efficacy for other neuropsychological symptoms: Threepatients in vegetative state regained consciousness, and one patient canmove around easily. With the exception of no improvement for two casesof aphasia, and two cases of dysphasia, all other symptoms are eithercured or notably improved. BuNaoGao has clearly demonstrated potenttherapeutic efficacy for paralysis caused by head/spinal cord trauma.

EXAMPLE 4 BuNaoGao in the Treatment of 23 Patients with Motor NeuronDisease (2, 35)

4.1. General Information

This clinical trial was carried out between January, 1989 and December,1992 by the Provincial Hospital of Chinese Medicine, Lanzhou, GanSuProvince.

Total cases: 23 cases

20 cases hospitalized,

3 cases outpatient

Age: Range 24 to 68 years of age (average 44 years)

4 cases (20-29 years of age),

2 cases (30-39 years of age),

7 cases (40-49 years of age),

8 cases (50-59 years of age),

2 cases (over 60 years of age).

Stage of Progression:

2 cases mild (muscle strength grade III⁺˜V³¹ , no bulbar syndromes).

8 cases moderate (muscle strength grade II⁺˜III, no bulbar syndromes.

13 cases Severe (muscle strength grade 0˜II or with bulbar syndromes.

11 out of the 23 patients had bulbar syndromes. Most cases had beentreated elsewhere before being included in the BuNaoGao trial.

Duration of Illness:

4 cases<1 year

9 cases 1-3 years

4 cases 3-5 years

3 cases 5-7 years

2 cases 7-10 years,

1 case>10 years.

EMG: 20 cases were tested for EMG, and all suggested damage of neuronalorigin.

Clinical Diagnosis:

Amyotrophic lateral sclerosis: 13 cases

7 cases without bulbar syndromes,

6 cases with bulbar syndromes.

Primary lateral sclerosis: 8 cases

4 cases without bulbar syndromes,

4 cases with bulbar syndromes.

Progressive muscular atrophy: 2 cases

1 case without bulbar syndromes,

1 case with bulbar syndromes.

Complications and Concomitant Conditions:

3 cases with coronary heart disease,

1 case with cerebral infarct,

1 case with hepatitis B,

4 cases with lung infection,

1 case with respiratory palsy.

ECG: 20 cases tested

10 cases normal,

4 cases with insufficient coronary blood supply,

3 cases right heart enlargement

1 case incomplete right-bundle block

2 cases incomplete left-bundle block (frontal branch)

Lingual diagnosis: (a diagnostic technique by observing the texture,color and moisture of the coating and the substance of the tongue)

Substance of tongue:

4 cases pinkish (Dan Hong);

4 cases red (Hong);

3 cases dark red (Hong An);

6 cases dark plain (Dan An);

6 cases plain (Dan);

Tongue coating:

16 cases white coating (Bai);

1 case white glossy coating(Bai Ni);

3 cases yellow coating (Huang);

3 cases yellow glossy coating (Huang Ni).

Pulse:

16 cases fine pulse (Xi Mai)

6 cases stringy pulse (Xuan Mai)

1 case rapid pulse (Shu Mai)

4.2 Treatment Strategy

BuNaoGao alone, taken orally 2 cubes/day

7 cases—finished 30-day treatment

5 cases—finished 60-day treatment

4 cases—finished 90-day treatment

7 cases—finished over 90-day treatment

Due to the often fast-deteriorating nature of this disease and theethical issues involved, no control group was set up for this study.

4.3 Criteria for Therapeutic Efficacy

Due to the already well-established course of development for thisdisease, efficacy of the treatment is evaluated based on patients'pre-treatment conditions and the trend of deterioration.

Clinically cured: disappearance of bulbar palsy, muscle strengthimproved to grade V.

Notable effect: bulbar palsy significantly improved, muscle strengthimproved more than 2 grade.

Effective: bulbar palsy improved, muscle strength improved more than 1grade.

No effect: bulbar palsy continue to exist, no improvement of musclestrength or improvement was less than 1 grade.

Deteriorated: continuous deterioration of symptoms or death.

4.4 Results (Table 4.1)

TABLE 4.1 Therapeutic efficacy of BuNaoGao on motor-neuron diseases (23cases) mild moderate severe Total 2 8 13  cured 1 notable 3 2 effective2 3 8 no effect 1 2 deteriorated 1 Total effective 2/2 7/8 10/13

In this study, to the one ALS patient who died during the period of ourevaluation, a 3-cubes/day dosage was used at the late stage in an effortto get his conditions under control, and some positive effects wereobserved even at the very late stage. This patient had been repeatedlytreated by BuNaoCao during the 8-year period after the initialdiagnosis, and he made improvements in prior episodes of BuNaoGaotreatment. This patient belonged to the fast-deteriorating type.According to the inventor's experience, if untreated, this patient'snatural course of disease may be 2-3 years. This patient appeared tohave a family history of similar disorders.

In our experience, the 2-cubes/day dosage was adequate for mostpatients. When this dosage failed to get the condition under control, a3-cubes/day dosage (1.5 times of the daily dosage) was used. As soon asthe patient's condition was stabilized, the dosage was reduced to theusual 2-cubes/day dosage. Although no side effect had been seen with the3-cubes/day dosage, patients were not advised to go on this high dosageunnecessarily.

4.5. Strategy for Longer-Term Treatment

After the clinical evaluation during the stated periods, patients weredischarged from the hospital when considered clinically safe. Mostpatients took 0.5-1 year's supply of BuNaoGao for continued treatment asoutpatients.

Every three-month treatment was considered as one cycle. Patients wereadvised to take a one-week break after each three-month cycle to avoidany potential side effects (on the condition that the disease was in areasonably stable condition). After taking BuNaoGao for 3-6 months, ifthe disease showed no sign of comeback after BuNaoGao was stopped, thesepatients could stop taking BuNaoGao. However, patients were advised tobe back on BuNaoGao immediately as soon as there was a concern (or anysigns) suggesting a comeback of the disease.

Some patients remained stable for many years without continuously takingBuNaoGao; some patients had to be back on BuNaoGao for more cycles oftreatment when the problems resurfaced. Due to the lack of an effectivefollow-up mechanism for this disease in our system, long-term follow-updata is not yet available, and this information may become available ata later date.

All patients were advised to avoid stressful situations of all kinds,physical exercise was not recommended for muscle strengthening in thisdisease.

4.6. Examples of Typical Cases

In addition to the above-summarized report, the following cases reportsgave more detailed description of changes in patients with this type ofdisease.

Case #1 (Amyotrophic Lateral Sclerosis) (12)

Patient: A 50-year-old female (Administration number #69834).Progressive upper limbs weakness for approximately 9 months, wasadmitted to the hospital on Sept. 18, 1992 with the diagnosis ofamyotrophic lateral sclerosis (ALS). The patient begun feeling upperlimb weakness without any known reason, later experienced difficulty ofraising arms and were unable to unbutton her clothes, and also feltweakness on both lower limbs. EMG (done at other hospital): muscleabnormality of neuronal origin, all nerves tested showed abnormalitiesof different extents; Diagnosis by other hospital: amyotrophic lateralsclerosis (ALS); After failed all other regular treatments of bothChinese and Western Medicines, and with a progressively worseningcondition, the patient was admitted to our hospital. Uponhospitalization: the patient showed weakness of all tour limbs, couldnot raise her upper limbs above shoulder, both hands could not dogripping and stretching, could not unbutton her clothes, difficulty oflifting her feet while walking with a feeling of rigidity, could only goup and down stairs by holding onto railing, could see muscle jumping allover her body. Tongue: pink red, with a thin white coat, fine pulse.Physical exam: Cranial nerves (normal); obvious atrophy of thenarmuscles interosseous muscles and forearm muscles and fasciculation, andmuscle strength III⁻; no muscle atrophy in the lower limbs, and musclestrength III⁺; muscle tone of four limbs (low); reflexs of ankle-jerk,Biceps-jerk, Triceps-jerk and Knee-jerk are all hyperactive; Unable toinduce pathological reflexes. No abnormalities of bladder control andbowel movement; No abnormality in sensory. Diagnosis according toWestern Medicine: amyotrophic lateral sclerosis (ALS). Diagnosisaccording to Chinese Medicine: Wei Zheng (belong to insufficiencies ofliver and kidney, and insufficiencies of Qi and blood), therefore thetreatment strategy require nourishment of liver, kidney, Qi and blood.Treatment given: BuNaoGao (two cubes/day) alone. Two weeks afterBuNaoGao; increased muscle strength in four limbs, could raise upperlimbs above head but could not stretch straight; reduced rigidity in thelower limbs and reduced muscle jumping in whole body. One month afterBuNaoGao; could raise upper limbs above should and could stretchstraight, could do up and down stairs more freely than before. Twomonths after BuNaoGao, all five fingers of both hands could stretch outand could unbutton clothes, could go up and down stairs easily, musclestrength III⁺-V⁻. After being considered to have made an notableimprovement, the patient was discharged from the hospital.

Case #2 (Amyotrophic Lateral Sclerosis) (13)

Patient: A 25-year-old male (Administration number #73819). Weakness offour limbs for approximately one year, was admitted to the hospital onAug. 7, 1993 with the diagnosis of amyotrophic lateral sclerosis (ALS).Upon hospitalization; the patient showed weakness of all four limbs,weak gripping (only 5 Kg), obvious muscle atrophy of four limbs and bothhands, twitching of both both upper limbs, unsteady walking (could onlymanage 100 meters), difficulty of walking up and down stairs. Tongue:red, with white coat, fine pulse. Physical exam: Lung and heart (−),muscle strength of four limbs (grade III), muscle tone (normal), tendonreflex (hyperactive), Babinski sign on both sides (+), Hoffmann sign onboth sides (+); EMG: injury of neuronal origin. Diagnosis according toChinese Medicine: Wei Zheng (liver and kidney weakness); Diagnosisaccording to Western Medicine: amyotrophic lateral sclerosis (ALS).Treatment strategy: BuNaoGao (two cubes/day) alone. 20 days afterBuNaoGao: slightly enriched muscle volume, walking more steadily thanbefore, gripping of both hands increased from 5 Kg to 20 Kg, could walkby himself for 2-3 hours, could walk up and down stairs by himselfrather easily, muscle strength of four limbs V-. After one-monthtreatment with BuNaoGao, significant improvement was observed and thepatient was discharged.

Case #3 (Primary Lateral Sclerosis) (14)

Patient: A 51-year-old male with a 6-month history of weakness in fourlimbs and lower limb rigidity, and was diagnosed by neurologists ofother hospitals as “lateral sclerosis”. His symptoms worsenedcontinuously despite all the treatments with both Chinese and Westernmedicines before being admitted to our hospital.

Diagnosis: Primary Lateral Sclerosis.

After treatment with a decoction modified from “Fu Shou San”, thepatient showed improved in muscle strength after 15 day's treatment, andcan climb stairs without the need for aid (still had difficulty of goingdownstairs) after 20 day's treatment; he can walk freely (still withsome weakness) after 35 day's treatment. After 80 day's treatment, thepatient's muscle strength reach grade V (still slight weakness), couldwalk up and down stairs easily and had normal gait. His pathologicalreflexes disappeared, and physiological reflexes of four limbs were onlyslightly active.This patient was treated with a decoction when the cube form of BuNaoGao(or the consensus formulation) was not yet invented, nevertheless thisreport reflected one of the early attempts by the inventor to define atherapeutic rule (or consensus formulation) for treating this type ofdisease.4.7. Side Effects

Due to the rather rapidly deteriorating nature of motor neuron disease(particularly ALS), and the potential of a long-term repeated use ofBuNaoGao for these patients, the following advice and precautions weregiven to patients: This formulation was designed to be used alonewithout anticipating further combination with other drugs or supplementswithout proper medical supervision. Furthermore, people with certainmedical conditions may put themselves at risk by using this formulation:i.e. (a) people with hypertension with blood pressure above 150/90 mmHgmay put themselves at risk by taking this formulation without firstlowing their blood pressure to a clinically safe level; (b) people withproblems with blood clotting (i.e. bleeding tendency) may put themselvesat risk by taking this formulation due to the anti-coagulating effect ofthis formulation; (c) Women in pregnancy or lactation should not usethis formulation.

The only known side-effect of this formulation in people with suitablemedical conditions (according to the experience of more than 25 years)has been an increased bowel movement, a problem which will usuallyresolve by itself within the first one or two weeks' usage. Despite theanti-coagulation effect of the formulation, no bleeding tendency has sofar been reported from our long-term experience. For longer-term usage,a one-week break after every three-months usage is recommended.

4.8 Conclusion

Most patients treated by BuNaoGao has failed conventional treatmentelsewhere (both Chinese and Western medicines). BuNaoGao has shown to beeffective for treating motor-neuron disease with a total effective rateof 82.61% during the period of our evaluation. During the follow-upperiod (though incomplete), some patients (including some ALS patients)remained stable for many years without continuously using BuNaoGao; Someother ALS patients experienced the comeback of the disease severaltimes. In every occasion of the disease comeback, BuNaoGao haddemonstrated its beneficial effect on slowing the disease progression.BuNaoGao has demonstrated a significant effect on slowing-down theprogression of ALS and other forms of motor neuron diseases. Given thesevere nature of the disease, continuous treatment under monitoring andearly treatment is always highly recommended.

During the period of 2000-2007, BuNaoGao for ALS/MND management wasexplored on a larger scale in the western patients' population. Furtherinformation will be entered upon completion of this work or uponrequest.

EXAMPLE 5 Treatment of Patients in Vegetative State (Total Four Cases)(15,16)

Patient #1: An 18-year-old female, in a vegetative state for 10 monthsafter initial head injury. After taking BuNaoGao (cube form) for 10days, she appeared to be in a slightly conscious state and to be able torecognize people; on the 15^(th) day, she was able to swallow food andfeeding tube was removed; on 20^(th) day, she was able to speak simplewords and could recognize her parents, had some improvement on limbmuscle strength (strength grade I); Two months after BuNaoGao, sheshowed continued improvement on consciousness and intelligence (couldremember her date of birth, could call out the names of her classmate,could tell Dr. Xia that “Uncle Xia, I have lost my intelligence”, couldtranslate a few English words into Chinese), etc (note: this is only apartial translation) (16).

Patient #2: A 17-year-old female, in a vegetative state for 6 monthafter brain surgery. Diagnosis: Injury to cerebral and brain stem, coma,de-celebral rigidity (vegetative state). 14 days after taking BuNaoGao,she appeared to be in a slightly conscious state and to be able torecognize objects; 20 days after taking BuNaoGao, she could answer yesor no with her eyes and could express her emotions; one month aftertaking BuNaoGao, she regained a clear consciousness, muscle strength hadimproved with decreased rigidity; Two month after taking BuNaoGao, shecould speak simple sentences; 70 days after taking BuNaoGao, she couldsit up, turn her neck, muscle strength in four limbs (I-III), reducedmuscle rigidity, and decerebrate rigidity was relieved. (Note: this isonly a partial translation) (16).

Patient #3: An 8-year-old girl with a three-month history of paralysisand in vegetative state (post encephalitis). Three month prior, thepatient was admitted to a hospital due to a high fever followed by astate of coma, and was diagnosed as type B encephalitis. Both CT and EEGrevealed widespread damage and abnormality of cerebral cortex. Aftervarious emergency treatments, she remained to be in a state of dementia,quadriplegia, tracheotomy, opisthotonus, a vegetative state. Aftertreatment with a decoction of Chinese Medicine (with constantmodifications) for 15 days, she started to show clinical improvements;after 30 days treatment, she made significant improvements (i.e. couldspeak simple words, muscle strength improved, etc.); After 60 daystreatment, her intelligence was close to normal, could speak normally.After another month of treatment using the decoction at a reduced dosage(every other day treatment), she had a complete recovery (15). 6 yearslater (at age of 14 years), the patient came back for a follow-up. Shewas completely normal, and was an outstanding student in her class(middle school) (note: this follow-up result was not in the originalpublication, was documented in the patient's record in the hospital).

EXAMPLE 6 Treatment of Oliverpontocerebellar Atrophy (Dejerine-ThomasType, 3 cases) (17)

There are two types of oliverpontocerebellar atrophy: hereditary (Menzeltype) and sporadic (Dejerine-Thomas type). All three cases treated herebelong to the latter and had failed long-term conventional treatmentelsewhere (both Western and Chinese Medicines). The followings arereports of the three cases.

Treatment strategy; Oral intake of BuNaoGao, 2 cubes/day. No additionalmedication was used.

Case #1: 40-year-old male with a 4-year history.

Notable effect was achieved after 100 day's treatment.

Case #2: 47-year-old male with a 2-year history.

Notable effect was achieved after 120 day's treatment,

Case #3: 60-year-old female with a 3-year history. Notable effect wasachieved after 30 day's treatment.

EXAMPLE 7 Treatment of Hereditary Cerebellar Ataxia (3 cases) (18)

All three cases treated have failed long-term conventional treatmentelsewhere (both Western and Chinese Medicines).

Treatment strategy: Oral intake of BuNaoGao, 2 cubes/day. No additionalmedication was used.

Case #1: 23-year-old male with two-year history. Notable effect wasachieved after 30 day's treatment.

Case #2: 48-year-old Female with five-year history. Notable effect wasachieved after 60 day's treatment.

Case #3: 75-year-old male with one-year history. Notable effect wasachieved after 30 day's treatment.

EXAMPLE 8 Treatment of Dementia

Many patients (mainly as outpatients) with senile dementia were treatedwith BuNaoGao. Significant improvements have been observed in many ofthese patients, detailed information will become available later on orupon request. Over 50 patients with dementia caused by apoplepxy werealso treated with BuNaoGao with satisfactory effect. Detailed result canbe further entered later or upon request.

EXAMPLE 9 Treatment of 52 Patients with Sequel of Apoplexy withFe-Shou-Yi-Qi-Ho-Xie” Decoction for (19).

Satisfactory therapeutic efficacy was observed with this self-designeddecoction and its various modifications used. The decoctions reportedhere lacked one of the core ingredients in the currently appliedformulation- “the BuNaoGao” formulation. And additional components,which were not used in “the BuNaoGao” formulation, were also added.Other case reports using similar principle had demonstrated satisfactoryresults (20-22). The currently applied formulation- “the BuNaoGao”formulation have all the key ingredient for achieving above clinicaleffect, also based on the inventor's experience of using BuNaoGao (cubeform or decoction) in some patients with similar conditions, thecurrently applied formulation is therefore considered potentially aseffective as the decoction reported for treating this type ofconditions.

EXAMPLE 10 Treatment of 50 Patients of Apoplexy Combined withPseudo-Bulbar Palsy (22).

Dysphasia (Gou Yin Bu Quan):

-   Total effective rate 98% (notable effect 58%)-   Dysphagia (Tuen Yian Kun Nan) and choking:-   Total effective rate 98% (notable effect 94%)

The decoction reported here lacked one of the core ingredients in thecurrently applied formulation- “the BuNaoGao” formulation. Andadditional components, which were not used in “the BuNaoGao”formulation, were also added. This study reflected one of the earlyattempts by the inventor to define a therapeutic rule (or consensusformulation) for treating this type of disease. The currently appliedformulation- “the BuNaoGao” formulation have all the key ingredient forachieving above clinical effect, and is therefore expected to bepotentially as effective as the decoction reported.

EXAMPLE 11 Treatment of Encephalopathy

Case #1: sequel of toxic encephalopathy (five months) (23)

-   Patient: A 5-year-old boy (administration # 71928) Dementia,    aphasia, could not stand or walk, very low intelligence (DQ=13).    After hospitalization, he was treated with BuNaoGao (one cube/day).    10 days after treatment, he was able to walk with just a little    assistance by others; 1 month later, he could walk by himself for    1-2 steps, could say “mum”; 2 month later, he could walk more    steadily, and could walk for five meters on his own, muscle strength    of both lower limbs IV⁺. He was considered to have made a notable    improvement and was discharged from the hospital.

Case #2: Delayed encephalopathy caused by carbon monoxide poisoning (1month) (internal record of the hospital)

-   Patient: A 63-year-old male with a prior history of carbon-monoxide    poisoning for one month. He was in a state of coma with frequent    convulsion of extremities; EEG showed severe abnormality and CT    revealed brain atrophy. After BuNaoGao (2 cubes/day) treatment for 2    weeks, he regained consciousness, and could recognize people, but    still had aphasia; One month after BuNaoGao, he could speak simple    words; 2 months after BuNaoGao, he could walk by himself, also he    could speak fluently and answer questions correctly. EEG and brain    CT all returned to normal.

EXAMPLE 12 Treatment of Multiple Sclerosis (MS)

More than three cases of patients with multiple sclerosis have beentreated. More complete information regarding these patients will beentered at a later stage or upon request

Case #1: A 50-year-old male patient with a 2-year history, and worseningcondition for two months (24).

Significant clinical improvement was observed after treatment for 30-35days using a decoction that bore some resemblance to BuNaoGao. However,it lacked one of the core ingredient of BuNaoGao, and many non-BuNaoGaoingredients were also used at various points. This patient did not haveany relapse during the follow-up period of one and half-years. Thisreport reflected one of the early attempts by the inventor to define atherapeutic rule (or consensus formulation) for treating this type ofdisease.

Case #2. A female outpatient in her early twenties diagnosed withmultiple sclerosis by other hospitals (also by the inventor): Within theone year before BuNaoGao was used, she had 5-6 relapses, and wasseverely handicapped and was in serious condition. After taking BuNaoGab(similar to Example 1) alone for two weeks, she started showingsignificant clinical improvements. She took BuNaoGao on a daily basisfor 2 years, and then on a 2-3-times/week basis. Being followed up bythe inventor for the last 8 years, she has not had a single relapse eversince (only one minor fluctuation which may not be qualified as arelapse). Although still feeling weak at times, she was able to resumenormal work and normal life (unpublished information).

Case #3. A male Caucasian patient in his late fifties with thenon-relapsing type of MS with lower limb involvement (require a cane forslow walking in the house) was treated with BuNaoGao full dosage for oneyear. No significant progression was observed during the one year whenhe was on full dosage and the subsequent 1.5 year follow up when hestopped BuNaoGao. By the time of 1.5 year follow up, he needed a walkerto walk around the house. Lower limb remains the only limb involved(unpublished information)

EXAMPLE 13 Treatment of Myelitis (25-26).

Case #1: Acute myelitis (26)

-   Patient: A 37-year-old female, weakness of lower limbs and urine    retention for 6 days. The patient had a cold two weeks prior the    weakness. BuNaoGao (the cube/tar form, example 1 of the current    application) was given at a 2-cubes/day dosage. On the 6th days of    BuNaoGao treatment, urine retention was resolved, and urethral    catheter was removed; On the 10th day after BuNaoGao, she could walk    on flat ground with a cane; on 20^(th) day after BuNaoGao, she could    walk freely with a normal gait, and could walk up and down stairs    without aid, the muscle strength of four limbs reached grade V, but    the painful sensation around waist somewhat remained. She continued    to be on BuNaoGao for another two months, and clinical cure was    achieved in this patient.

Case #2: Sequel of neuromyelitis optica (Devic disease, note by thetranslator) (25).

-   Patient: A 27-year-old female patient with one-year history.    Clinical cure was achieved in this patient after 27 day's treatment    using a decoction that bore some resemblance to BuNaoGao. However,    this formulation did not have the consensus of this current BuNaoGao    application, and many additional ingredients were also included at    various points. Although no well-controlled clinical trial was    conducted on myelitis of all types, based on the experience and the    theory of the inventor, it is predicted that the currently applied    formulation should have therapeutic effect on this type of disease.

EXAMPLE 14 Treatment of Polyneuritis (Polyneuropathy)

14. 1-Case Report (16)

Patient: A 59-year-old male. 6 month's prior, he started experiencingnumbness of hands and feet, with a slightly painful sensation. He wasafraid of cold and his condition got worse when encountered coldness. Hefailed other treatments of Western and Chinese Medicines. He had nohistory of severe illness or drug intake. Examination: in addition tohand and feet numbness, his hands and feet were cold, his whole body wasweak. Neurological examination:

weakness of hands and feet; slightly lower muscle tone in four limbs;hypoactive tendon reflexes; reduced sensory to pain, touch andtemperature below the ½ of all forelimbs; reduced sensory to sound atangles and wrist. Diagnosis: polyneuritis. Clinical cure was achievedafter a one-month treatment with decoctions of Chinese medicine.

Decoctions used for this patient at various points eventually had usedall ingredients comprised in the current BuNaoGao formula, and severalnon-BuNaoGao ingredients were also used. It was then believed that thecurrently applied formulation should have a beneficial effect on thisdisease as well as all other types of polyneuritis.

14.2 A Clinical Study of BuNaoGao Effect on Peripheral Polyneuritis (28)

54 cases were hospitalized and treated with BuNaoGao using the standarddosage of 2 lozenges/day, for 1-3 months.

Control group of 36 cases were treated with HuangQiGuiZhiTang(HuangQiGuizhiWuWuTang). 1 standard dosage per day, for 1-3 months.Control group treatment also combined with multiple vitamins.

TABLE 14.1 BuNaoGao effect on Peripheral Polyneuritis Total EffectiveCase Cured Improved No effect Rate (%) BuNaoGao 54 25 (46%) 26 (48%) 3(5%) 51 (94.5%) group Control group 36  9 (25%) 18 (50%) 9 (25%) 27(75%)

The above result demonstrated therapeutic efficacy of BuNaoGao forperipheral polyneuritis in a controlled study. BuNaoGao result issignificantly better than the control treatment group (P<0.01).

REFERENCES

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1. A method of treating head or spinal cord injuries, comprising thestep of administering to a patient in need thereof a compositingconsisting essentially of Radix angelica sinensis (DangGui) 0.82.-3.3g/kg body weight, Ligusticum chuanxiong (ChuanXiong) 0.1-1.2 g/kg bodyweight, Hirudo (ShuiZhi) 0.1-0.4 g/kg body weight, Polygonatum sibiricum(HuangJing) 0.2-0.8 g/kg body weight, Glycyrrhiza uralensis (Gancao)0.06-0.21 g/kg body weight, Astragalus membranaceus (HuangQi) 0.315g-1.2 g/Kg body weight, Curculigo orchioides (XianMao) 0.1-1 g/Kg bodyweight, epimedium grandiflorum (YinYangHuo) 0.1-1 g/Kg body weight,Psoralea corylifolia (Bucuzhi) 0.1-1 g/Kg body weight, Leonurusheterophyllus (YiMucao) 0.1-1 g/Rg body weight, and Paeonia rubrae(Chishao) 0.1-1 g/Kg body weight, wherein the g/kg body weight dosagescan be increased up to 2.5 times if the body weight of the patient isless than 40 kg.
 2. The method of claim 1, wherein Ligusticum chuanxiong(ChuanXiong) is replaced by Carthamus tinctorius (Hong Hua) 0.1-1.2 g/kgbody weight.
 3. The method of claim 1, wherein the composition isadministered daily.
 4. A method of treating head or spinal cordinjuries, comprising the step of administering to a patient in needthereof a compositing consisting essentially of Radix angelica sinensis(DangGui) 0.82-3.3 g/kg body weight, Ligusticum chuanxiong (ChuanXiong)0.1-1.2 g/kg body weight, Hirudo (ShuiZhi) 0.1-0.4 g/kg body weight,Polygonatum sibiricum (HuangJing) 0.2-0.8 g/kg body weight, Glycyrrhizauralensis (Gancao) 0.06-0.21 g/kg body weight, Astragalus membranaceus(HuangQi) 0.315 g-1.2 g/Kg body weight, Lycium chinensis mill (GouQiZi)0.1-1 g/Kg body weight, Curculigo orchioides (XianMao) 0.1-1 g/Kg bodyweight, epimedium grandiflorum (YinYangHuo) 0.1-1 g/Kg body weight,Cornus officinalis (ShanZhuYu) 0.1-1 g/Rg body weight, Psoraleacorylifolia (BuGuZhi) 0.1-1 g/Kg body weight, Leonurus heterophyllus(YiMucao) 0.1-1 g/Kg body weight, and Paeonia rubrae (Chishao) 0.1-1g/Kg body weight, wherein the g/kg body weight dosages can be increasedup to 2.5 times if the body weight of the patient is less than 40 kg. 5.The method of claim 4, wherein Ligusticum chuanxiong (ChuanXiong) isreplaced by Cartharnus tinctorius (Hong Hua) 0.1-1.2 g/kg body weight.6. The method of claim 4, wherein the composition is administered daily.